The Impact of Riboflavin on the Severity and Duration of Sports Related Concussion

Not Applicable

Completed

• Conditions: Sports Related Concussion
• Interventions: Drug: Riboflavin 400mg daily

• Registration Number: NCT02235337
• Lead Sponsor: University of Virginia

Brief Summary

The purpose of this study is to investigate the effectiveness of riboflavin to decrease the duration of time for a student-athlete to return to participation in sports after a sports related concussion.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-09-04
• Study First Submitted QC: 2014-09-08
• Study First Posted: 2014-09-09
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-09
• Last Update Posted: 2017-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 248

Inclusion Criteria

• All UVa and JMU student-athletes over the age of 18 years old who are diagnosed with a sports related concussion

Exclusion Criteria

• Less than 18 years old
• Greater than 24 hours have elapsed since the concussion occurred.
• The student-athlete has already participated in the study during which he/she took Riboflavin
• Non-sports related concussion not incurred while participating in the sport or training for the sport. As an example, a student-athlete who sustains a concussion as a result of a motor vehicle accident will be excluded from the study for that concussion

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Riboflavin	Riboflavin 400mg daily	-

Primary Outcome Measures

Name	Time	Method
Time to return to full participation in sports after a sports related concussion	21 days or less

Trial Locations

Locations (2)

James Madison University; 🇺🇸 Harrisonburg, Virginia, United States

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States